Author: Novartis Europharm Ltd.


Long information

What is it?

Afinitor is a medicine that contains the active substance everolimus. It is available as pale yellow, elongated tablets (5 and 10 mg).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Afinitor is used to treat patients with advanced renal cell carcinoma (kidney cancer that has started to spread). It is used when the cancer has got worse during or after previous treatment with a medicine that targets vascular endothelial growth factor (VEGF). VEGF is a protein that stimulates the formation of blood vessels.
Because the number of patients with renal cell carcinoma is low, the disease is considered ?rare?, and Afinitor was designated an ?orphan medicine? (a medicine used in rare diseases) on 5 June 2007. The medicine can only be obtained with a prescription.

How is it used?

Treatment with Afinitor should be started and supervised by a doctor who has experience in the use of anticancer treatments.
The recommended dose of Afinitor is 10 mg once a day. Treatment should continue for as long as the patient benefits from it or until the patient develops unacceptable side effects. The doctor may reduce the dose or stop treatment for a short period if the patient has severe or intolerable side effects. The tablets should be swallowed whole at the same time every day and should not be chewed or crushed. They should be taken consistently with or without food.

How does it work?

The active substance in Afinitor, everolimus, is an anticancer medicine, which acts by blocking a protein called ?mammalian target of rapamycin? (mTOR). In the body, everolimus attaches to a protein that is found inside cells to make a ?complex?. This complex then blocks mTOR. Since mTOR is involved in the control of cell division and the growth of blood vessels, Afinitor prevents the division of cancer cells and reduces their blood supply. This slows down the growth and spread of kidney cancer.

How has it been studied?

The effects of Afinitor were first tested in experimental models before being studied in humans.

Afinitor was compared with placebo (a dummy treatment) in one main study involving 416 patients with advanced renal cell carcinoma that had got worse within six months of stopping treatment with medicines that target VEGF (sunitinib, sorafenib or both). All of the patients also received best supportive care (any medicines or techniques to help patients, but not other anticancer medicines). The main measure of effectiveness was how long the patients lived without the disease getting worse.

What benefits has it shown during the studies?

Afinitor was more effective than placebo at treating patients with advanced renal cell carcinoma. The patients who took Afinitor lived for an average of 4.9 months without the disease getting worse, compared with 1.9 months for the patients who took placebo.

What is the risk associated?

The most common side effects with Afinitor (seen in more than 1 patient in 10) are infections, low levels of lymphocytes and neutrophils (types of white blood cell), haemoglobin (the protein found in red blood cells that carries oxygen around the body) and platelets (components that help the blood to clot), increased levels of glucose (sugar), cholesterol and triglycerides (types of fat) and phosphate, loss of appetite, abnormal taste, pneumonitis (inflammation in the lungs), dyspnoea (difficulty breathing), epistaxis (nosebleeds), cough, stomatitis (inflammation of the lining of the mouth), diarrhoea, mucosal inflammation (inflammation of the moist body surfaces), vomiting, nausea (feeling sick), increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes), rash, dry skin, pruritus (itching), increased levels of creatinine (a breakdown product of muscle), fatigue (tiredness), asthenia (weakness) and peripheral oedema (swelling of the arms and legs). For the full list of all side effects reported with Afinitor, see the Package Leaflet.
Afinitor should not be used in people who may be hypersensitive (allergic) to everolimus, to other rapamycin derivatives (substances with a similar structure to everolimus) or to any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Afinitor?s benefits are greater than its risks for the treatment of patients with advanced renal cell carcinoma whose disease has progressed on or after treatment with VEGF-targeted therapy. The Committee recommended that Afinitor be given marketing authorisation.

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